Licencias necesarias e Información técnica
|Clarification and Recovery of Recombinant Proteins using a Cascade Tangential Flow Filtration (TFF) System|
|Pellicon® 2 Filters and Holders|
|Visión general referencias|
|Tetanus Toxoid Purification: A Case Study
Vancetto, Mary Dalva Caparroz, Jose Marcos de Oliveira, Sally Muller Affonso Prado, Fernando Fratelli, and Hisako Gondo Higashi; Nature Biotechnology Volume 15
Nature Biotechnology Volume 15 1997
|Evaluation of Microporous Tangential-Flow Filtration in the Production of Diphtheria and Pertussis Vaccines
Rao, Y. Udaya Bhaskara, M.S. Mahadevan, and Stephen L. Michaels; Pharmaceutical Technology
Pharmaceutical Technology 1992
|Validation of Tangential Flow Filtration (TFF) Systems
Michaels, Stephen L.
Journal of Parenteral Science and Technology (Sept/Oct 1991). 1991
|Can the Pellicon II cassettes be used with older Pellicon holder?||Yes, the new Pellicon II cassettes may be used the old Pellicon I holder. They will fit for operation without any adaptation.|
|How many cassettes can fit into the Pellicon II Mini holder at one time?||The Pellicon II Mini holder can hold from one to three of the Mini cassettes at one time. As a general rule of thumb, for every 10 L of process volume, add a cassette to the system.|
|What are the materials of construction for the Pellicon cassettes?||The cassettes are made of the specified membrane material, polypropylene screens, and a polyurethane adhesive. When checking compatibility with a particular solution, it is necessary to check compatibility with all of these materials.|
|What are the recommended tangential flow rates for each of the screen channel products in the Pellicon cassettes?||For the A Screen modules, there is a recommended flow rate of 4-9 L/min/m2.
For the C screen modules, there is a recommended flow rate of 9.5- 14.6 L/min/m2.
For the V Channel modules, there is a recommended flow rate of 19.6- 33 L/min/m2.
|Are the TFF membranes autoclavable or steam sterilizable?||The membranes for Pellicon XL, Helicon UF, Helicon RO, spiral wound/prep/scale, Prostak UF and Pellicon 2 are not autoclavable or steam sterilizable. However, a chemical sanitization can be done; refer to the maintenance manual for these membranes.
Note: Prostak Open Channel with microporous Durapore membranes can be steam sterilized.
|What pH range is compatible with my Pellicon membrane?||The pH ranges are listed on the data sheets: The PES is 1-14 and the Regenerated Cellulose is 2-13|
|What is Normalized Water Permeability?||NWP is a measure of the ability of pure water to pass through the filter membrane. NWP is a property of the TFF system and is contributed to by the membrane as well as the feed and permeate flow paths in the filter.|
|How is NWP measured?||NWP is measured by filtering pure water throught he system at controlled cross flow, Trans Membrane Pressure and temperature. The filtrate flow rate is measured. The flow rate is normalized to the membrane area, TMP and temperature.
Please refer to the operator's manual or contact Techical Service for further questions regarding the calculation of NWP.
|How does NWP aid in effective cleaning procedure development?||Fouling and polarization leave residues on the membrane that can reduce filter permeability. Effective cleaning removes these residues, restoring the permeability of the membrane. Ideally, NWP after cleaning should equal NWP before use although there can be variation up to +/-15% due to membrane compaction under pressure and measurement error.
NWP validates the ability of cleaning to restore filtration rate of a system.
|What is the hold-up volume of a Pellicon 2 Mini cassette?||The approximate hold-up volume for a Pellicon 2 mini cassette (0.1m2) is 18 ml upstream and 10 ml downstream.|
|What is the hold-up volume for a Pellicon 2 Maxi cassette (2.5m2)?||The approximate hold up volume for the Pellicon 2 Maxi cassettes is 450 ml on the feed side and 250 ml on the permeate side.|
|Are there any microporous offerings in the tangential flow filtration line of products?||While the Prep/Scale and Pellicon XL are not available in a microporous format, the Pellicon II Mini and Pellicon II systems are. The microporous membranes are made of Millipore's Durapore membrane, low protein binding PVDF, and are available in 0.1um, 0.22um, 0.45um, and 0.65um.|
|What is the hold up volume for a 0.5m2 Pellicon 2 cassette?||The approximate hold up volume is 90 ml on the feed side and 50 ml on the permeate side.|
|What is the length of the retentate and permeate channel in the Pellicon platform cassettes?||The length of the retentate and permeate channel is 15.5 cm.|
|Is there a prefiltration requirement for use with the Pellicon system?||Yes, the Pellicon system requires a 100um prefiltration. Depending on the process volume, Millipore offers an array of prefiltration modules. Contact Technical Services for help in choosing a module.|
|With the Pellicon 2 Modules, when should I use A vs C vs V screen?||A screen (tight screen):
Dilute protein solution or low viscosity solutions (Mab’s, interferons)
C screen (coarse screen):
Concentrated protein solutions or high viscosity solutions (IgG, biopolymers)
V screen (loose screen):
High viscosity solutions (polysaccharides, certain microfiltration or clarification applications).